eonatal European Study of Inhaled Steroids

Phase 1

• Conditions: Risk of Bronchopulmonary Dysplasia at Very Preterm Infants; MedDRA version: 14.1Level: PTClassification code 10006475Term: Bronchopulmonary dysplasiaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2009-012203-26-GR
• Lead Sponsor: niversity Children's Hospital, Department of Neonatology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-08
• Study Completion: 2016-07-31
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 863

Inclusion Criteria

A gestational age of 23 0/7 - 27 6/7 weeks, a postnatal age < 12 hours, the requirement for any form of positive pressure support (mechanical or nasal ventilation or CPAP) and parental consent for participation
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A clinical decision not to administer therapies (infant not considered viable), dysmorphic features or congenital malformations that adversely affect life expectancy or neurodevelopment and known or suspected congenital heart disease (not including a persistent ductus arteriosus and/or atrium septum defect). The clinical assessment of dysmorphic features, congenital malformations, suspected congenital heart disease and the decision to exclude an infant for the above mentioned reasons will be left to the discretion of the attending physician.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified